InferRead CT Stroke.AI
InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital…
InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of intracranial hemorrhage (ICH).
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
Record
| Listed by | Infervision US Inc |
|---|---|
| FDA product code | QAS |
| Device type | Radiological Computer-Assisted Triage And Notification Software |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2080 |
| 510(k) | K211179 |
| Record published | 2021-08-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.1.0.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Viz LVO | Viz.ai, Inc. | 12 |
| Triage Stroke | Brainomix Limited | 5 |
| BriefCase Triage | Aidoc Medical Ltd. | 5 |
| Triage LVO | Brainomix Limited | 5 |
| BriefCase | Aidoc Medical Ltd. | 3 |
| HealthICH | Nano-X AI Ltd. | 3 |
| Annalise Triage | Harrison-AI Medical Pty Ltd | 3 |
| Triage ICH | Brainomix Limited | 3 |
| syngo.CT Brain Hemorrhage | Siemens Healthcare Limited | 2 |
| AccipioIx | Maxq AI Ltd | 2 |
| Viz ICH | Viz.ai, Inc. | 2 |
| qER | Qure.ai Technologies Private Limited | 1 |
Showing 12 of 29. All products under Radiological Computer-Assisted Triage And Notification Software
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.